CMC Regulatory Leader - US & LatAm - Biologicals - Raleigh, North Carolina

Employer
Advanced S&S (USA)
Location
RTP, NC
Salary
On Application
Closing date
14 Oct 2020

View more

Discipline
Regulatory Affairs, CMC, Compliance
Hours
Full Time
Contract Type
Permanent
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CMC Regulatory Leader - US & LatAm - Biologicals - Raleigh, North Carolina

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

Organization

My client is one of the industry’s best success stories in the bio-/pharmaceutical sector, and have doubled their R&D spend and revenue pretty much consistently every 5-7 years since I have first worked with them 15 years ago. This is one organization which can offer individuals with a ‘can do’ and ‘let’s make it happen’ approach, a match in terms of culture and working style.

The Team

The Regulatory CMC team, works directly with Process Development, Analytics, Technical Services and mfg and supply chain to ensure IMP development and first BLA filings are supported, and then for lifecycle, to manage DS and DP changes, new market entry and new injectors are delivered to the patient and markets in a timely manner.

The Role

This role is for CMC RA strategy, liaison and delivery role (as a matrix leader for local RA CMC Sr Managers around the world), as you will devise and implement the overall strategies for 2 well-known marketed products, and then drive the teams in matrix to deliver the submissions.

We want someone who has both FDA and LatAm experience, who wants to also manage other international and core markets (EMA and AP) through your matrix reports and regional liaisons. It will develop into a global role.

Experience Required

You will have the following experiences to be eligible for this role:-

  • Direct US BLA Or PAS, CBEs or international Variations experience for DS and DP
  • Have managed US plus 1 other region (ideally LatAm) in a Regulatory CMC Liaison role
  • Have worked with CMC sub teams on major DS and DP changes for either recombinants, plasmids or mAbs
  • Any Spanish language skills would be useful (advantageous but not a pre-requisite)
  • Be willing and able to work in Boston, Cambridge or Raleigh / Durham, North Carolina

Package

In return, my client is willing to pay competitive (better than most) packages, including a high performing stock plan with decent vesting timelines, performance bonus and decent medical / insurances and extra-legal benefits.

For compelling candidates a relocation package is available.
 

To Apply!

To apply, please contact Matt or Theo on 855.505.1382 to find out more about this role and other available positions we have. Alternately, please send me a full CV to matt@advtalent.com and I will respond to you by return.

About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our team know our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

Contact us today to see how we can help you make that next career move on

+44 (0)207 801 3380

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8, Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +1 855-505-1382
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